NCT06654141 Influence of Healing Time on the Outcomes of Alveolar Ridge Preservation in Periodontally Compromised Extraction Sockets
| NCT ID | NCT06654141 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University |
| Condition | Tooth Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2025-02-06 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to histologically, clinically, and radiographically evaluate the healing sequelae of periodontally compromised extraction sockets grafted with Bio-Oss Collagen® at 3 and 6 months following tooth extraction in molar sites. The main question it aims to answer is: Does healing time influence the histologic, clinical, and radiographic outcomes following socket grafting (alveolar ridge preservation) in periodontally compromised extraction sockets. Researchers will compare a healing time of 3 months to a healing time of 6 months (conventional healing duration) to see if a shorter duration is viable for implant placement. Participants will: Take a cone-beam computed tomography (CBCT) scan to prepare for the surgical procedure. Undergo tooth extraction and the extraction socket will be grafted with Bio-Oss Collagen® and a collagen membrane Bio-Gide® will be placed to stabilize the graft material. Return at 2 weeks for suture removal and either 3- or 6-months post-extraction for implant placement. Return at 2 weeks post-implant placement for suture removal, 3 months for prosthesis fabrication, 4 months for final prosthesis loading, and 1 year post-loading.
Eligibility Criteria
Inclusion Criteria: * 18 years of age or older * ASA (American Society of Anesthesia) status I or II * Need for molar extraction due to periodontal disease with or without chronic endodontic involvement, complying with the presentation of periodontitis stage III/IV * Radiographic evidence of a bone dehiscence on at least one socket wall, where the height of the horizontal (suprabony) component of the defect (alveolar bone crest - cement-enamel junction) is \>50% of the corresponding root length as measured on CBCT scans prior to extraction (Ben Amara et al., 2021) * Radiographic evidence of at least 3 mm of residual bone wall height * Presence of at least one adjacent tooth to the extraction site * Treatment plan must include tooth replacement with an implant-supported fixed dental prosthesis Exclusion Criteria: * Extraction of multiple adjacent teeth * Acute infection associated with the tooth to be extracted or with adjacent teeth * Current smokers (\>10 cigarettes per day) * Uncontrolled diabetes mellitus (HbA1c \>7.0) * Any active oral or systemic acute infections * Currently receiving chemo- or radiotherapy or a history of radiotherapy in the head and neck area * Diseases or medications that may compromise normal wound healing
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06654141 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tooth Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06654141 currently recruiting?
Yes, NCT06654141 is actively recruiting participants. Contact the research team at xinboyu@proton.me for enrollment information.
Where is the NCT06654141 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06654141 clinical trial?
NCT06654141 is sponsored by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University. The trial plans to enroll 42 participants.